[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59135-59136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19915]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval
of a New Animal Drug Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight new animal drug applications (NADAs) at the sponsor's request
because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 8, 2016.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, [email protected].
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has
requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:
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21 CFR
File No. Product name section
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012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B).
013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
[[Page 59136]]
013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B) Premix.
015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
127-507 \1\............ TYLAN 5 SULFA-G (tylosin 558.630
phosphate and sulfamethazine),
TYLAN 10 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 20 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 40 SULFA-G (tylosin
phosphate and sulfamethazine).
141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355
(monensin).
141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363
MONTEBAN (narasin).
141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550
BIO-COX (salinomycin).
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\1\ These NADAs were identified as being affected by guidance for
industry #213, ``New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of
Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209,'' December
2013.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
012-548, 013-162, 013-388, 015-166, 127-507, 141-164, 141-170, and 141-
198, and all supplements and amendments thereto, is hereby withdrawn,
effective September 8, 2016.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19915 Filed 8-26-16; 8:45 am]
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